NCT04984577

Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

Phase II Trial of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke -- a Multi-center, Randomized, Double-blind, Parallel, Multi-doses and Active-controlled Study

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Nanjing Yoko Biomedical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Compound Edaravone Injection-Low dose	Compound Edaravone Injection 30mg/dose (Edaravone 30mg, Taurine 600 mg), one dose every 12 hours, continue for 14 days
DRUG	Compound Edaravone Injection-High dose	Compound Edaravone Injection 50mg/dose (Edaravone 50mg, Taurine 1000 mg), one dose every 12 hours, continue for 14 days
DRUG	Edaravone Injection	Edaravone Injection 30mg/dose, one dose every 12 hours, continue for 14 days
DRUG	Placebo injection	Placebo injection, one dose every 12 hours, continue for 14 days

Timeline

• Start date: 2021-11-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-07-30
• Last updated: 2024-02-20

Locations

1 site across 1 country: China